I-FACTOR PEPTIDE ENHANCED BONE GRAFT
FDA premarket approval P140019/S001 · decided 2016-03-17
Approval details
- PMA number
- P140019
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- I-FACTOR PEPTIDE ENHANCED BONE GRAFT
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, LLC
- Date received
- 2015-12-03
- Decision date
- 2016-03-17
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Approval of the protocol for the ODE Lead PMA Post-Approval Study.
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